Primary immunization of healthy children in the first year of life against poliomyelitis, diphtheria, tetanus and pertussis.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. A male or female aged 3 months including at the time of the vaccination. Written informed consent obtained from the parent of the subject. Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don’t have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis according to the list of contraindications stated in me-thodical guidance 3.3.1.1095-02 “Medical contraindications and prophylactic vaccination by National Calendar of Immunisations” and Instructions on medical use of PoliorixTM and InfanrixTM vaccines. Are the trial subjects under 18? yes Number of subjects for this age range: 400 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs from birth. Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic. Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product. Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation. Medical history of convulsions and progressive neurological disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Chronic diseases and serious congenital defects. Acute disease at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reactogenicity and safety assessment of co-administration of GlaxoSmithKline (GSK) Biologicals’ inactivated poliomyelitis vaccine PoliorixTM and GlaxoSmithKline (GSK) Biologicals’ DTPa-vaccine InfanrixTM in frame of three-doses primary im-munization course in healthy children of 3, 4.5 and 6 months on age in Russian Federation.;Secondary Objective: Not applicable;Primary end point(s): Occurrence of solicited local and general adverse events (AE) . Occurrence of unsolicited adverse events (AE). Occurrence of serious adverse events.;Timepoint(s) of evaluation of this end point: For occurrence of solicited local and general adverse events (AE) : During 4 days follow-up period (Day 0 to Day 3) after admini-stration of each vaccine dose. For occurrence of unsolicited adverse events (AE): During 31 days follow-up period (Day 0 to Day 30) after admin-istration of each vaccine dose. For occurrence of serious adverse events: During the entire study period (Visit 1 to Visit 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Russian Federation
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed